Chronic migraine with medication overuse: Treatment outcome and disability at 3 years follow-up
University of West Florida, Pensacola, Florida, United States Neurological Sciences
(Impact Factor: 1.45).
11/2004; 25 Suppl 3(S3):S272-3. DOI: 10.1007/s10072-004-0306-4
Patients with chronic migraine and medication overuse are particularly difficult to treat. No clear consensus exists about treatment strategies to be used and little data exists about the functional impact of headache in these patients. The purpose of the study was to determine (1) the clinical course of a sample of chronic migraine patients with medication overuse 36 months following treatment intervention and (2) whether functional impairment, assessed by the Migraine Disability Assessment (MIDAS) questionnaire, improved upon treatment. Of 106 patients meeting the criteria for chronic migraine with medication overuse (according to Silberstein and Lipton), 71 went on to complete a structured inpatient treatment, consisting of medication withdrawal and then prophylactic treatment. As a group, the patients were significantly improved at 36-month follow-up, with respect to 2 headache parameters (days of headache per month and number of used medications per month assessed by the diary card) and 2 measures of functional impact extracted from the MIDAS questionnaire (MIDAS total score and frequency of headache). Chronic migraine accompanied with medication overuse led to considerable disability prior to treatment. However, notable improvement both in headache parameters and in disability measures occurred concurrently with treatment. This suggests that successful treatment has more wide-ranging positive benefits beyond mere symptom reduction. To our knowledge, this is the first investigation where the MIDAS questionnaire has been used as an outcome measure in patients with chronic headache to assess disability during such a long follow-up period.
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- "Sembla que aquests pacients que presenten abús de medicació responen menys als tractaments profilàctics; no obstant, alguns estudis no coincideixen en aquesta afirmació. Usai et al., (2004) avaluen la resposta clínica de 106 pacients amb migranya crònica i abús de medicació a la retirada de medicació i tractament preventiu. Observen una millora significativa en el nombre de dies de cefalea al mes, la quantitat de medicació presa al mes i la puntuació total en el qüestionari de incapacitat (MIDAS) després de tres anys. "
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ABSTRACT: The Short Form-36 (SF-36) and Migraine Disability Assessment (MIDAS) questionnaires are two of the most commonly used tools to measure outcomes in people suffering from headaches. Nevertheless, little is known about their interrelationship in patients with headache.
The aim of this study was to investigate the interrelationship between SF-36 and MIDAS questionnaires in patients with migraine.
We enrolled 231 patients with migraine (male/female: 43/188, mean age 35.3+/-8.1) who visited our headache clinic. They completed the SF-36, MIDAS, and a headache intake form.
The correlation coefficients between the MIDAS score and 8 domains of the SF-36 ranged from -0.30 for the mental health domain to -0.53 for the social functioning domain (P<0.01). Canonical correlation analysis showed that the overall overlap between the 2 instruments was moderately strong (canonical correlation coefficients r=0.707 and 0.572). The overall measured redundancies for MIDAS and SF-36 scales in this study were 35.4% and 11.5%, respectively. The stepwise linear regression model showed that the social functioning domain alone explained 27.9% of variance in the MIDAS scores. Bodily pain, physical functioning, and general health domains added an additional 11.4% of the explained variance in the regression model.
Despite the fact that these two measures were considerably correlated, the MIDAS and SF-36 were found to measure different aspects of the impact of headache for the sample investigated. The MIDAS questionnaire does not cover the emotional domain; therefore, an accompanying psychological questionnaire might help assess the outcome for headache studies.
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ABSTRACT: Chronic migraine is a disabling primary chronic daily headache disorder that significantly impacts the daily activities of patients with this disorder. To our knowledge, this is the first report of a large, randomized, double-blind, placebo-controlled trial that assessed the impact of topiramate on the daily activities, emotional distress, headache-related disability, and global impression of change in patients with chronic migraine.
To assess whether topiramate 100 mg/day reduces migraine-related disability and limitations of daily activities in patients with chronic migraine.
Patients aged > or =18 years with chronic migraine were randomized 1 : 1 ratio to topiramate 100 mg/day or placebo. The double-blind period lasted 16 weeks. Three patient-reported outcome measures were administered: Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire (Domains: Role Function Restrictive and Preventive and Emotional Function), and Subject's Global Impression of Change. Investigators completed a Physician's Global Impression of Change for each patient. Subject's Global Impression of Change and Physician's Global Impression of Change were completed one time, at the end of study, and measured on a 7-point scale (1 = very much improved to 7 = very much worse). The Migraine-Specific Quality of Life Questionnaire was analyzed using analysis of covariance (last observation carried forward) approach. Results were not adjusted for multiplicity.
A total of 328 patients were randomized (topiramate, n = 165; placebo, n = 163), and 306 patients were included in the intent-to-treat population. Mean age was 38.2 years, and a majority of the patients were female (85.3%). Fifty-six percent of topiramate-treated patients vs 45% of placebo-treated patients reported >50% improvement from baseline in Migraine Disability Assessment scores (P = .074). The Migraine-Specific Quality of Life Questionnaire analysis demonstrated significant improvements at week 4 in all 3 domains, and at weeks 8 and 16 in both Role Function-Restrictive and Emotional Function domains (P < .05). Role Function-Preventive approached, but did not reach significance, at week 8 (P = .053). Seventy-five percent and 72% of topiramate-treated patients vs 61% and 59% of placebo-treated patients reported improvements on the Subject and Physician's Global Impression of Change scales (P = .025 and P = .037, respectively).
Compared with placebo-treated patients, topiramate 100 mg/day appears to contribute to reductions in migraine-related limitations on daily activities and emotional distress beginning as early as week 4 and continuing up to week 16 after treatment. Physician's Global Impression of Change results are very similar with Subject's Global Impression of Change, indicating concordance between the physician's and the subject's assessment of improvement.
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